Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to determine the safety and tolerability of single doses of SBI-087 in subjects with rheumatoid arthritis.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

SBI-087

Group Type EXPERIMENTAL

SBI-087

Intervention Type DRUG

Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg.

Interventions

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SBI-087

Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
* Must meet criteria for rheumatoid arthritis with functional class I to III.
* Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age

Exclusion Criteria

* Any significant health problems other than rheumatoid arthritis.
* Treatment of greater than 10 mg of prednisone per day.
* Treatment with cyclophosphamide.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No